Prescription medicine
Avacopan Brand names: Tavneos
Avacopan (Tavneos) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the avacopan FDA label on DailyMed (effective June 2, 2026, ChemoCentryx, Inc.); the NDA 214487 record on Drugs@FDA; every avacopan label on DailyMed.
Highlights of the record
FDA label of June 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTAVNEOS is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids.
Forms and strengths
- 10 mg
Capsule.
On the market
- Earliest approval on file
- October 7, 2021 Tavneos, Chemocentryx; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 27, 2039 Tavneos capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,343 through July 30, 2026
What is avacopan used for?
From the label: indications and usageTAVNEOS is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use. TAVNEOS is a complement 5a receptor (C5aR) antagonist indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. […]
FDA pharmacologic class: Complement 5a Receptor Antagonist.
Source: FDA drug label (TAVNEOS), ChemoCentryx, Inc., effective June 2, 2026 (SPL set c93cbc0b-29a3-46a5-9c85-41815ea5cf4a), via openFDA; the full label on DailyMed
What does the patient leaflet for avacopan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TAVNEOS?TAVNEOS may cause serious side effects, including: Liver problems. People taking TAVNEOS may have serious liver problems, including a type of liver injury called vanishing bile duct syndrome (VBDS) that causes the loss of bile ducts in the liver. VBDS is severe and can lead to death.VBDS has been reported predominantly in Japan in patients aged 65 years and older but can happen to anyone. Call your healthcare provider right away if you have unexplained symptoms such as: yellowing of your skin or the white part of your eyes (jaundice) itchy skin (pruritus) pain on the upper right side of your stomach area (abdomen) feeling tired dark or brown (tea colored) urine bleeding or bruising more easily than normal loss of appetite Your healthcare provider will do blood tests to check how well your liver is working before starting and during your treatment with TAVNEOS. If you are of Japanese descent, your healthcare provider may recommend additional liver function testing and monitoring.
From the patient leaflet: How should I store TAVNEOS?Store TAVNEOS capsules at room temperature between 68°F to 77°F (20°C to 25°C). Keep TAVNEOS and all medicines out of reach of children.
Source: FDA drug label (TAVNEOS), ChemoCentryx, Inc., effective June 2, 2026 (SPL set c93cbc0b-29a3-46a5-9c85-41815ea5cf4a), via openFDA; the full label on DailyMed
Is there a generic for avacopan (Tavneos)?
No generic avacopan is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Tavneos capsules: the compound patent runs to November 27, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2039 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the avacopan label say about other medicines?
The avacopan label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Itraconazole | drug interactions | Avacopan exposure is increased when co-administered with strong CYP3A4 enzyme inhibitors such as itraconazole [see Clinical Pharmacology (12.3) ]. |
| Rifampin | drug interactions | Avacopan exposure is decreased when co-administered with strong CYP3A4 enzyme inducers such as rifampin [see Clinical Pharmacology (12.3) ]. |
| Simvastatin | drug interactions | Co-administration of avacopan and 40 mg simvastatin increases the systemic exposure of simvastatin. |
Source: FDA drug label (TAVNEOS), ChemoCentryx, Inc., effective June 2, 2026 (SPL set c93cbc0b-29a3-46a5-9c85-41815ea5cf4a), via openFDA; the full label on DailyMed
What do FAERS reports show for avacopan?
The FDA Adverse Event Reporting System holds 6,343 reports that list avacopan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 639 are coded as a death and 2,880 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,726, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Avacopan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other